Medikinet 50 mg modified-release hard capsules

Patient Information Leaflet

Introduction

Patient Information Leaflet

Medikinet 50 mg modified-release hard capsules

methylphenidate hydrochloride

Read the entire leaflet carefully before you or your child start taking this medicine, because it contains important information for you. Keep this leaflet, as you may need to read it again. If you have any questions, consult your doctor or pharmacist. This medicine has been prescribed for you or your child; do not give it to others, even if they have the same symptoms as you, as it may harm them. If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Package leaflet

1. What Medikinet is and what it is used for

2. What you need to know before you or your child start taking Medikinet

3. How to take Medikinet

4. Possible side effects

5. How to store Medikinet

1. Contents of the pack and other information

1. What Medikinet is and what it is used for

What it is used for

Medikinet is used to treat "attention deficit hyperactivity disorder" (ADHD).

• It is used in children aged 6 years and older and in adults.
• It is used only after non-medicinal treatments, such as behavioural therapy and counselling, have been tried and have proven insufficient.

Medikinet is not indicated for the treatment of ADHD in children under 6 years of age.

How it works

Medikinet improves the activity of certain parts of the brain that are underactive. The medicine may help improve attention and concentration levels and reduce impulsive behaviour.

The medicine is administered as part of a comprehensive treatment programme, which usually includes psychological, educational, and social therapy.

Treatment with Medikinet should only be initiated by a physician who is a specialist in the treatment of ADHD, such as a specialist paediatrician, child and adolescent psychiatrist, or psychiatrist, and must be used under their supervision. This physician should perform a thorough medical assessment. If you, as an adult, have not previously received such treatment, the physician will carry out tests to confirm that you have had ADHD since childhood. Although ADHD cannot be cured, it can be managed using comprehensive treatment programmes.

About ADHD

Children and adolescents with ADHD have:

• difficulty staying still and
• difficulty concentrating.

It is not their fault that they cannot do these things.

Patients may have varying degrees of ADHD, with symptoms such as:

• lack of concentration
• restlessness
• hyperactivity
• impulsiveness
• emotional instability
• disorganised thinking

Some of the external signs are:

• difficulty concentrating
• forgetfulness
• excessive talking (talkativeness)
• difficulty planning and completing tasks
• impulsive actions
• impatience

ADHD does not affect the intelligence of the child or adolescent.

2. What you need to know before you or your child start taking Medikinet

Do not take Medikinet if you or your child

• are allergic to methylphenidate or any of the other ingredients of this medicine (listed in section 6)
• have a thyroid problem
• have high eye pressure (glaucoma)
• have a tumor of the adrenal glands (pheochromocytoma)
• have an eating disorder, lack of appetite, or do not want to eat, such as in “anorexia nervosa”
• have very high blood pressure or narrowing of blood vessels, which may cause pain in the arms and legs
• have ever had heart problems, such as a heart attack, irregular heartbeat, chest pain or discomfort, heart failure, heart disease, or a congenital heart problem
• have ever had a problem with blood vessels in the brain such as stroke, dilation or weakness in part of a blood vessel (aneurysm), narrowing or blockage of blood vessels, or inflammation of blood vessels (vasculitis)
• are taking or have taken within the last 14 days an antidepressant (known as a monoamine oxidase inhibitor); see “Taking Medikinet with other medicines”
• have mental health problems, such as:

- a “psychopathic” disorder or “borderline personality disorder”

- abnormal thoughts or hallucinations or a condition called “schizophrenia”

- signs of a serious mood disorder, such as:

• suicidal thoughts
• severe depression, feeling very sad, worthless, and hopeless
• mania, feeling unusually elated, more active than normal, and disinhibited
• have a history of marked lack of stomach acidity (gastric acid deficiency) with pH values above 5.5
• are being treated with medicines to reduce gastric acid secretion or to treat excessive stomach acidity (H2 receptor blockers, proton pump inhibitors, or treatment with antacids).

Do not take methylphenidate if you or your child have any of the above conditions. If you are unsure, inform your doctor or pharmacist before you or your child take methylphenidate. This is because methylphenidate may worsen these conditions.

Warnings and precautions

Consult your doctor before starting Medikinet if you or your child

• have liver or kidney problems

• have difficulty swallowing or trouble swallowing whole tablets

• have ever had seizures (fits, convulsions, epilepsy) or any abnormalities in the electroencephalogram (EEG, a test of brain activity)

• have ever abused alcohol, prescription medicines, or illegal drugs, or have been dependent on them

• are a woman who has started menstruating (see section “Pregnancy and breastfeeding” below)

• have difficulty controlling repetitive movements of certain body parts or repeat sounds and words (tics)

• have high blood pressure

• have a heart problem not included in the section above “Do not take”

• have a mental health problem not included in the section above “Do not take”. Other mental health problems include:

• mood swings (from manic to depressed, known as “bipolar disorder”)

• experiencing aggressive or hostile behavior, or worsening of aggression

• seeing, hearing, or feeling things that are not there (hallucinations)

• believing things that are not real (delusions)

• feeling unusually suspicious (paranoia)

• feeling restless, anxious, or tense

• feeling depressed or guilty.

Inform your doctor or pharmacist if you or your child have any of the above conditions before starting treatment. Methylphenidate may worsen these problems. Your doctor will want to monitor how the medicine affects you or your child.

During treatment, children and adolescents may unexpectedly experience prolonged erections. These erections may be painful and can occur at any time. It is important to contact a doctor immediately if an erection lasts longer than 2 hours, especially if it is painful.

If you or your child experience blurred vision or other visual disturbances, contact your doctor. Your doctor may consider stopping treatment with Medikinet.

Checks your doctor will make before you or your child start treatment with methylphenidate

To decide whether methylphenidate is the right medicine for you or your child, your doctor will discuss with you:

• the medicines you or your child are taking
• whether there is a family history of unexplained sudden death
• other illnesses you or your family may have (such as heart problems)
• how you or your child are feeling; for example, if you have mood swings, strange thoughts, or have had such feelings in the past
• whether there have been cases of tics in your family (difficulty controlling repetitive movements of certain body parts or repeated sounds and words)
• any possible behavioral or mental health problems you or your child or other family members may have had.

Your doctor will specifically explain whether you or your child are at risk of mood changes (from manic to depressed, known as bipolar disorder). Your doctor will also review your or your child’s mental health history and check whether any family members have a history of suicide, bipolar disorder, or depression.

It is important that you provide as much information as possible. This will help your doctor decide whether methylphenidate is the right medicine for you or your child. Your doctor may decide that you or your child need further medical tests before starting this medicine. For adult patients starting Medikinet, your doctor may refer you to a heart specialist.

Drug testing

This medicine may give positive results in drug tests.

Athletes should be aware that this medicine may produce a positive result in doping control tests.

Taking Medikinet with other medicines

Inform your doctor or pharmacist if you or your child are taking, have recently taken, or might need to take any other medicines.

Do not take methylphenidate if you or your child:

• are taking a medicine called “monoamine oxidase inhibitor” (MAOI) used for depression, or have taken an MAOI within the last 14 days. Using an MAOI with methylphenidate may cause a sudden increase in blood pressure.

If you or your child are taking other medicines, methylphenidate could affect how these medicines work or cause adverse effects. Inform your doctor if you or your child are taking medicines to treat:

• depression
• mental health problems
• epilepsy
• blood pressure problems
• cough and cold. Some remedies contain medicines that may affect blood pressure, so it is important to consult your pharmacist before buying such a product
• medicines that thin the blood to prevent clotting.

Medikinet should not be taken together with H2 receptor blockers, proton pump inhibitors, or antacids (medicines to reduce stomach acid secretion or to treat excessive stomach acidity), as they may cause a faster release of the total amount of active ingredient.

If you have any doubts about whether any of the medicines you or your child are taking are included in the list above, consult your doctor or pharmacist for advice before taking Medikinet.

Before surgery

Inform your doctor if you or your child are due to have surgery. Methylphenidate should not be taken on the day of surgery when certain types of anesthetics are used, as this may cause a sudden increase in blood pressure during the procedure.

Taking methylphenidate with alcohol

Do not drink alcohol while taking this medicine. Alcohol may worsen the adverse effects of this medicine. Remember that some foods and medicines contain alcohol.

Pregnancy and breastfeeding

Available data do not suggest an increased risk of overall congenital malformations, although a small increased risk of cardiac malformations during use in the first trimester of pregnancy could not be ruled out. Your doctor will provide further information about this risk.

Consult your doctor or pharmacist before using methylphenidate if you or your daughter:

• have sexual intercourse. Your doctor will discuss contraception with you.
• are pregnant or think you may be pregnant. Your doctor will decide whether you should take methylphenidate.
• are breastfeeding or plan to breastfeed. Methylphenidate may pass into human milk. Therefore, your doctor will decide whether you or your daughter should breastfeed while taking methylphenidate.

Driving and using machines

You or your child may experience dizziness, drowsiness, difficulty focusing, blurred vision, hallucinations, or other adverse effects affecting the central nervous system when taking methylphenidate. If this occurs, it may be dangerous to perform certain activities such as driving, operating machinery, riding a bicycle or horse, or climbing trees.

Medikinet contains sucrose

If your doctor has informed you that you or your child have an intolerance to certain sugars, consult him before taking this medicine.

Medikinet contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per capsule; that is, essentially “sodium-free”.

3. How to take Medikinet

Follow exactly the instructions given by your doctor for administering this medicine. If you are unsure, consult your doctor or pharmacist again.

Dosage

Use in children

The maximum daily dose is 60 mg.

• Your doctor will usually start treatment with a low dose and gradually increase it as needed.
• Your doctor will tell you the dose you need to take each day.
• Do not split the contents of a capsule; take the entire contents of the capsule.
• Medikinet should not be taken late in the morning, as it may cause sleep disturbances.

Use in adults

For adults who have previously taken Medikinet

• If you previously took Medikinet during childhood or adolescence, you may use the same daily dose (mg/day); your doctor will regularly check whether dose adjustment is necessary.
• Adult patients may require a higher daily dose, but your doctor will aim to give you the lowest effective dose.
• The maximum daily dose is based, among other factors, on your body weight (see below).

For adults who have not previously taken Medikinet

The recommended starting dose is 10 mg per day.

• Your doctor will increase your dose in 10 mg daily increments according to your tolerance and response to the medication.
• The goal should be to administer the lowest effective dose.
• The maximum daily dose is based, among other factors, on your body weight (see below).
• Your doctor will determine the maximum daily dose.
• The daily dose is 1 mg/kg body weight, up to a maximum of 80 mg of methylphenidate per day.

What your doctor will do during your or your child’s treatment

Your doctor will perform certain tests

• Before you or your child start treatment – to ensure that Medikinet is safe and will be beneficial.

• Once treatment has started – you or your child will be monitored at least every 6 months, and even more frequently, especially when the dose is changed.

• These tests will include:

• Monitoring of appetite

• Measurement of height and weight in children

• Measurement of weight in adults

• Measurement of blood pressure and heart rate

• Assessment of mood-related problems, mental state, or any other unusual feelings, or whether these have worsened while taking Medikinet.

How to take

This medicine is for oral use.

Medikinet should be administered to children in the morning with or after breakfast.

Medikinet should be administered to adults with or after breakfast and with or after lunch.

Medikinet is a "controlled-release" formulation of methylphenidate, which gradually releases the medicine over an extended period. It is very important to take the capsule with or after meals to prolong its effect.

Capsules may be swallowed whole with a little water or may be opened and the contents sprinkled onto a small amount (one tablespoon) of applesauce or yoghurt, and taken immediately. Do not store for future use.

The capsules and their contents must not be crushed or chewed.

If you or your child do not feel better after 1 month of treatment

If you or your child do not feel better after 1 month of treatment, inform your doctor. Your doctor may decide whether you or your child need a different treatment.

Long-term treatment

Medikinet does not need to be taken indefinitely. If you or your child take Medikinet for more than one year, your doctor should interrupt treatment at least once a year for a short period. In children, this interruption may be scheduled during school holidays. This allows assessment of whether the medicine is still needed.

Misuse of Medikinet

If Medikinet is misused, it may cause abnormal behavior. This may also mean that you or your child may become dependent on the medicine. Inform your doctor if you or your child have ever abused or been dependent on alcohol, prescription medicines, or illegal drugs.

This medicine has been prescribed for you only and must not be given to others, even if they have the same symptoms as you.

If you or your child take more Medikinet than you should

In case of overdose or accidental ingestion, contact your doctor, the nearest hospital emergency department, or the Toxicology Information Service immediately at telephone: 91 562 04 20, stating the medicine and the amount taken. Medical treatment may be required.

Signs of overdose may include: vomiting, agitation, tremors, increased uncontrolled movements, muscle twitching, seizures (sometimes followed by coma), feelings of extreme happiness, confusion, seeing, feeling, or hearing things that are not real (hallucinations), sweating, flushing, headache, high fever, changes in heartbeat (slow, fast, or irregular), high blood pressure, dilated pupils, dryness of the nose and mouth, muscle spasms, fever, and darkening of the urine to a reddish-brown color, which could be possible signs of abnormal muscle breakdown (rhabdomyolysis).

If you or your child forget to take Medikinet

Do not take a double dose to make up for missed doses. If you or your child forget a dose, wait and take the next dose at the scheduled time.

If you or your child stop taking Medikinet

If you or your child stop taking this medicine suddenly, ADHD symptoms or unwanted effects such as depression may return. Your doctor may wish to gradually reduce the amount of medicine you take each day before stopping completely. Consult your doctor before stopping treatment with Medikinet.

If you have any further questions about using this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them. Your doctor will inform you about these adverse effects.

Some adverse effects can be serious. If you or your child experience any of the following effects, contact your doctor immediately:

Frequent: may affect up to 1 in 10 people

• irregular heartbeat (palpitations)
• changes in personality
• excessive teeth grinding (bruxism)

Uncommon: may affect up to 1 in 100 people

• mood disturbances
• suicidal thoughts or feelings
• seeing or hearing things that are not real, symptoms of psychosis
• uncontrolled body movements or speech (Tourette’s syndrome) or worsening of these
• chest pain
• signs of allergy such as rash, itching or hives on the skin, swelling of the face, lips, tongue or other body parts, shortness of breath, difficulty or problems breathing

Rare: may affect up to 1 in 1,000 people

• feeling unusually elated, more active than normal and disinhibited (mania)

Very rare: may affect up to 1 in 10,000 people

• heart attack
• seizures (fits, epilepsy with convulsions)
• skin peeling or red-purple spots
• uncontrolled muscle spasms affecting the eyes, head, neck, body and nervous system, as a result of insufficient blood flow to the brain
• paralysis or movement and vision problems, difficulty speaking (these may be signs of problems with blood vessels in the brain), temporary lack of blood and oxygen supply (ischaemia) to the brain
• decrease in the number of blood cells (red blood cells, white blood cells and platelets), which may increase the risk of infections and cause easier bleeding and bruising
• sudden increase in body temperature, very high blood pressure and severe convulsions (“Neuroleptic Malignant Syndrome”). It is not entirely certain whether this adverse effect is caused by methylphenidate or by other medicines taken in combination with methylphenidate.

Not known: frequency cannot be estimated from the available data

• unwanted thoughts that keep recurring
• unexplained fainting, chest pain, shortness of breath (these may be signs of heart problems)

If you or your child experience any of the adverse effects listed above, contact your doctor immediately.

The following additional adverse effects are listed. If they become severe, please contact your doctor or pharmacist immediately:

Very common: may affect more than 1 in 10 people

• decreased appetite
• headache
• feeling nervous
• difficulty sleeping
• dry mouth
• feeling unwell

Common: may affect up to 1 in 10 people

• depression or lack of feelings or emotions, or showing excessive interest
• joint pain
• high temperature (fever)
• abnormal hair loss or reduced thickness (thinner hair)
• drowsiness or unusual drowsiness
• loss of appetite
• panic attack
• decreased sex drive
• toothache
• itching, rash or increased itching of red rashes (urticaria)
• cough, sore throat or irritation of the throat and nose, shortness of breath or chest pain
• changes in blood pressure (usually high blood pressure)
• fast heartbeat (tachycardia) or irregular heart rhythm (arrhythmia), cold hands and feet
• restlessness or tremor, dizziness
• uncontrolled movements, feeling of inner restlessness
• unusual activity
• aggression, agitation, restlessness, emotional instability, anxiety, depression, stress, irritable and abnormal behaviour, difficulty sleeping, fatigue
• stomach pain, diarrhoea, stomach discomfort, indigestion, thirst, vomiting. These adverse effects usually occur at the beginning of treatment and may be reduced by taking the medicine with food
• lack of appetite/no desire to eat
• weight loss
• excessive sweating

Uncommon: may affect up to 1 in 100 people

• restlessness or tremor
• muscle pain, muscle stiffness, muscle spasms
• constipation
• chest discomfort
• inflammation of the mucous membranes of the stomach and small intestine
• perception of extra heart sounds (based on scientific findings)
• blood in the urine
• double vision or blurred vision
• dry eyes
• increased liver test results (seen in blood tests)
• anger, feeling tearful, excessive awareness of surroundings, tension
• feeling very calm or drowsy
• generally, sleep problems
• fatigue

Rare: may affect up to 1 in 1,000 people

• changes or disturbances in sex drive
• feeling disoriented
• dilated pupils, vision problems
• breast swelling in men
• skin redness, increased redness of skin rashes
• pain due to insufficient blood flow to the heart
• problems / changes in menstruation
• obsessive-compulsive disorder (OCD) (including an irresistible urge to pull out body hair, pinch the skin, have repeated unwanted thoughts, feelings, images or impulses in the mind (obsessive thoughts), perform repeated mental behaviours or rituals (compulsions)).

Very rare: may affect up to 1 in 10,000 people

• heart attack
• sudden death
• muscle cramps
• small red spots on the skin
• inflammation or blockage of arteries in the brain
• abnormal liver function including liver failure and coma
• changes in test results, including liver and blood tests
• suicidal ideation (including suicide), abnormal thinking, loss of feelings or emotions
• lack of energy
• feeling sad for a short period of time
• numb and cold toes and fingers, tingling and colour change with cold (from white to blue, then red) (“Raynaud’s phenomenon”)

Not known: frequency cannot be estimated from the available data

• migraine
• very high fever
• slow or fast heartbeat or palpitations
• major epileptic seizure (“grand mal convulsions”)
• believing things that are not true
• confusion
• sad/dark thoughts
• feeling a physical need for the medication or its absence
• problems with blood vessels in the brain (stroke, cerebral arteritis or cerebral occlusion)
• erectile dysfunction
• prolonged erections, sometimes painful, or increased number of erections
• uncontrollable talkativeness
• after stopping the medication, ADHD symptoms may reappear or side effects may occur, such as depression
• tingling sensation
• problems with language and speech
• nausea
• attention disorders
• flu-like illness
• loss of energy / feeling weak
• thirst
• increases in levels of thyroid-stimulating hormone in the blood
• pain in the mouth and throat area
• nosebleeds
• heart discomfort
• increased eye pressure
• eye diseases that may cause vision loss due to optic nerve damage (glaucoma)
• stress with partner/family
• chest pain
• hot flushes / flushing
• ringing in the ears (tinnitus)
• abuse
• pancytopenia (abnormal decrease in the number of all blood cells)
• inability to control urination (incontinence)
• spasm of jaw muscles making it difficult to open the mouth (trismus)
• stuttering

Effects on growth

When taken for more than one year, methylphenidate may reduce growth in some children. This affects fewer than 1 in 10 children.

• it may prevent weight or height gain
• your doctor will carefully monitor your or your child’s height, weight and eating habits
• if you or your child do not grow as expected, treatment with methylphenidate may be interrupted for a short period.

Reporting of adverse effects:

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Medikinet

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the blister and on the outer packaging after EXP. The expiry date is the last day of the month indicated.

Do not store above 30°C.

Keep in the original packaging to protect the medicine from moisture.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at the SIGRE point in your pharmacy. Ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Package contents and other information

Composition of Medikinet

The active substance is: methylphenidate hydrochloride.

Each modified-release hard capsule contains 50 mg of methylphenidate hydrochloride, equivalent to 43.25 mg of methylphenidate.

Other components:

Capsule contents:

Sugar spheres (containing sucrose and maize starch), methacrylic acid-ethyl acrylate copolymer (1:1), talc, triethyl citrate, polyvinyl alcohol, macrogol 3350, polysorbate 80, sodium hydroxide, sodium lauryl sulfate, simethicone, anhydrous colloidal silica, methylcellulose, sorbic acid, indigo carmine, aluminium lake (E-132).

Capsule shell:

Gelatin, erythrosine (E-127), titanium dioxide (E-171), sodium lauryl sulfate, purified water, black iron oxide (E-172), indigo carmine (E-132).

Appearance of the medicine and contents of the pack

Violet opaque capsule body, dark violet opaque cap (18.0 mm), containing white and blue pellets.

Pack sizes: Blister packs of PVC/PVdC-aluminum containing 20, 24, 27, 28, 30, 36, 40, 45, 48, 54, 60, 90, 96 or 99 modified-release hard capsules.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

MEDICE Arzneimittel Pütter GmbH & Co. KG
Kuhloweg 37
58638 Iserlohn
Germany

Manufacturer:

MEDICE Arzneimittel Pütter GmbH & Co. KG
Kuhloweg 37
58638 Iserlohn
Germany

Local representative:

MEDICE Ibérica, S.L.
Muntaner 179, 3º 1ª
08036 Barcelona, Spain

This medicinal product is authorized in the European Economic Area (EEA) Member States and the United Kingdom (Northern Ireland) under the following names:

Germany: Medikinet retard 50 mg Hartkapseln mit veränderter Wirkstofffreisetzung
Austria: Medikinet retard 50 mg Hartkapseln mit veränderter Wirkstofffreisetzung
Denmark: Medikinet CR 50 mg
Spain: Medikinet 50 mg cápsulas duras de liberación modificada
Finland: Medikinet CR 50 mg
Iceland: Medikinet CR 50 mg hart hylki með breyttan losunarhraða
Luxembourg: Medikinet retard 50 mg Hartkapseln mit veränderter Wirkstofffreisetzung
Netherlands: Medikinet CR 50 mg capsule met gereguleerde afgifte, hard
Norway: Medikinet 50 mg Kapsel med modifisert frisetting, hard
Poland: Medikinet CR 50 mg
Sweden: Medikinet 50 mg Kapsel med modifierad frisättning, hård
United Kingdom: Medikinet XL 50 mg modified-release capsules hard
(Northern Ireland)

Date of the most recent revision of this leaflet: February 2026

Detailed information on this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS): http://www.aemps.gob.es